Kornimate/medical-research-clean huggingface dataset:
study of the zn-d5 and zn-c3 in subjects with acute myeloid leukemia (aml)

Conditions: Acute Myeloid Leukemia (AML)

Summary: a phase 1/2 dose escalation study of bcl-2 inhibitor zn-d5 and the wee1 inhibitor zn-c3 in subjects with acute myeloid leukemia (aml).

this is an open-label multicenter phase 1/2 dose escalation study, evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of the novel bcl-2 inhibitor zn-d5 and wee1 inhibitor zn-c3 in subjects with aml.

Eligibility criteria:
inclusion criteria: * adults with aml (including secondary or therapy-related), relapsed from or refractory to one or more prior lines of therapy, which may include venetoclax except in expansion cohort a * ecog performance status score ≤2. * projected life expectancy of at least 12 weeks. * estimated glomerular filtration rate ≥60 ml/min * women of childbearing potential must not be pregnant and must use effective birth control during the study and for 6 months after the last dose of study drugs. * men must agree to use a condom when having intercourse during the study and for 3 months after the last dose of study drugs. exclusion criteria: * known active cns involvement * diagnosis of acute promyelocytic leukemia. * peripheral blast count of \>25 × 109/l (cytoreduction permitted). * adequate washout from prior therapy including hematopoietic stem cell transplant and recovery from prior treatment-related toxicities to grade 2 or lower * significant cardiovascular disease * corrected qt interval (qtc) of \>480 msec * active hepatitis b or hepatitis c infection * concurrent treatment with strong cyp3a inhibitors or strong or moderate cyp3a inducers

Keywords: bcl-2 inhibitors wee1 inhibitors aml
genetic biomarkers associated with child language development in taiwan (ii)

Conditions: Child Language

Summary: a study of the relation between genetic biomarkers and child language development in taiwan.

the interaction between gene and environment (g×e) can be a very complicated process that influences child development. as a pilot study of child development biomarkers, this study investigates genes related to child language development and language disorder.

Eligibility criteria:
inclusion criteria: * age 2-18 y/o * agree to sign informed consent exclusion criteria of healthy child: * central nervous system disease * neuromuscular disorders * congenital abnormality * genetic disease * dysesthesia * hearing impairment inclusion criteria of child with language disorder: * patients with language disorder * age 2-18 y/o * agree to sign informed consent exclusion criteria of child with language disorder: * hearing impairment * inclusion criteria of adult: * his or her child participated in this study, and gene abnormality was found.

Keywords: language development gene whole-exome sequencing body function and body structure quality of life
a single ascending dose study of dt-216p2 in normal healthy participants

Conditions: Friedreich Ataxia

Summary: this purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of dt-216p2 administered either subcutaneously (sc) and intravenously (iv) in normal healthy participants. approximately 36 participants will be enrolled into this study.


Eligibility criteria:
inclusion criteria: * participants must be 18-45 years of age inclusive, at the time of signing the informed consent. * participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ecg. * agree to abstain from strenuous physical activity outside of daily norm, until end of study. * body mass index between 16 and 32 kg/m2 (inclusive) at screening; weight should be \<= 100 kg at screening. * male and/or female using protocol defined and regulatory approved contraception. * capable of giving signed informed consent. exclusion criteria: * any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study protocol. * any clinically significant nonmedical conditions and psychiatric disorders that could put the participant at higher risk for participation in the study, influence the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator. * is not willing to comply with the contraceptive requirements during the study period, as per protocol.
calcium and vitamin d malnutrition in elderly women

Conditions: Osteoporosis; Secondary Hyperparathyroidism

Summary: this study is designed to test whether calcium supplementation alone or calcium plus vitamin d reduces the incidence of fractures, reduces high parathyroid secretory activity, and halts bone loss in a population-based sample of women 55+ years of age. * a calcium supplement of 1400 mg/d will significantly reduce the cumulative incidence of spine and appendicular fractures over four years for independently living, rural women 55 years of age and older compared to similar women on their usual diets. * a calcium supplement of 1400 mg/d plus 1100 iu vitamin d/d will significantly reduce the cumulative incidence of spine and appendicular fractures compared to a calcium supplement only.

we are conducting a 4-year randomized, double-blind, placebo controlled trial of calcium or calcium with vitamin d supplementation. we randomly sampled the population of healthy, independent living women 55+ years in nine rural counties. we randomly assigned 1180 women to one of three groups: group 1 receives calcium (1400 mg/d) and vitamin d placebo, group 2 receives both calcium (1400 mg/d) and vitamin d (1100 iu/d) and group 3 receives both placebos. a full-service market research firm randomly selected telephone numbers from all households with listed numbers in the nine-county rural sample area. the firm continued calling until 1180 women were selected who met the inclusion and exclusion criteria and were willing to participate in a four year prospective study of calcium and vitamin d supplementation. the participants were enrolled into study between may 2000 and july 2001. participants have study visits every six months. annually the following are performed: bone density scans, height and weight, brief medical history including medicine changes, fracture surveillance, and compliance with calcium and vitamin d. at baseline and end of study, spine x-rays and dietary recall were obtained.

Eligibility criteria:
inclusion criteria: healthy women ages 55 and older who were at least four years postmenopausal living independently in a nine-county rural area of nebraska - exclusion criteria: 1) chronic kidney disease, 2) paget's metabolic bone disease, and 3) history of cancer except for superficial basal or squamous cell carcinoma of the skin and -

Keywords: calcium vitamin d secondary hyperparathyroidism osteoporotic fractures
efficacy and safety of roflumilast cream in subjects with atopic dermatitis

Conditions: Atopic Dermatitis (AD)

Summary: this study will assess the safety and efficacy of roflumilast cream versus vehicle applied once a day for 4 weeks by subjects with atopic dermatitis.

this is a parallel group, double blind, vehicle-controlled study in which roflumilast cream or vehicle is applied once daily for 4 weeks to subjects with mild or moderate atopic dermatitis.

Eligibility criteria:
inclusion criteria: 1. male or female subjects aged ≥ 6 years at screening. 2. diagnosed with atopic dermatitis (ad) for at least 6 months for subjects aged ≥18 years and 3 months for subjects aged 6\~17 years at screening. 3. have stable disease for the past 4 weeks prior to screening. 4. have mild or moderate ad at baseline. 5. have bsa affected by ad of 3%-20% at baseline. 6. women of childbearing potential (wocbp) have a negative pregnancy blood test at screening and a negative urine pregnancy test at baseline. wocbp must have taken and agree to continue taking highly effective contraceptive measures from 4 weeks before the first dose to 2 months after the last dose. 7. being in good health as judged by the investigator. 8. subjects voluntarily participate in the study and sign the icf before the start of study-related activities. exclusion criteria: 1. subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the investigator. 2. previous treatment with roflumilast cream. 3. use of systemic treatments that affect the efficacy assessment of ad 4 weeks or 5 half-lives (whichever is longer) prior to the first dose. 4. use of topical treatments that affect the efficacy assessment of ad 2 weeks prior to the first dose. 5. use of phototherapy, tanning beds, or any other light-emitting devices within 4 weeks prior to the first dose. 6. female subjects who are pregnant or breastfeeding, or plan to become pregnant or breastfeed during the study. 7. subjects with a history of chronic alcohol or drug abuse within 6 months prior to screening. 8. subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house. 9. subjects/legal guardians who are unable to communicate, understand the study, or other situations deemed inappropriate for participation in a clinical trial by the investigator.

Keywords: roflumilast cream atopic dermatitis
phase iib clinical trial of hamsa-1™ in metastatic castration resistant prostate cancer (crpc)

Conditions: Metastatic Castration Resistant Prostate Cancer (CRPC)

Summary: hamsa-1™ is an anti-angiogenic drug combination designed for the treatment of cancer. the investigational product hamsa-1™ comprises of four well-known active components. the therapy is administrated at a unique dosing regimen that was found to be effective and advantageous in terms of safety.the product is formulated as an oral suspension, conveniently administrated by the patients at home and not requiring medical staff assistance. this phase iib clinical trial aims to evaluate the efficacy of hamsa-1™ for the treatment of metastatic castration resistant prostate cancer (crpc) patients.


Eligibility criteria:
inclusion criteria: 1. subjects willing and able to give written informed consent 2. confirmed metastatic castration resistant prostate cancer and rising psa 3. ecog performance status ≤ 1 4. adequate renal function, hepatic function and bone marrow reserve. 5. subjects capable of swallowing. exclusion criteria: 1. hypersensitivity to one or more of the hamsa-1™ active components 2. glucose-6-phosphate-dehydrogenase deficiency (g6pd) 3. subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation 4. subjects who received any investigational medication, antineoplastic therapy, or any significant change in treatment within 1 month prior to screening 5. subjects with visceral metastases (e.g. liver, lung) 6. subjects who received more than 2 prior chemotherapies for the treatment of prostate cancer 7. subjects suffering from circumstances likely to interfere with absorption of orally administrated drugs 8. subjects unwilling to or unable to comply with study protocol

Keywords: crpc hrpc metastatic prostate cancer
psychoeducational programme for pd patients with stn-dbs

Conditions: Parkinson's Disease

Summary: bilateral subthalamic deep-brain stimulation is a well-established therapeutic option to improve motor signs and reduce dopaminergic treatment and related motor complications in patients with severe forms of parkinson's disease (pd). however, psychological disorders and socio-familial maladjustment are less clearly improved with subthalamic stimulation with an aggravation of the social adjustment described in about 1/3 of cases, with work disruption, divorce or familial conflict. the caregivers have also been reported to present negative well-being after surgery with an aggravation of the quality of life. in the present study, the investigators evaluate the effects of a perioperative psychoeducational programme to avoid postoperative socio-familial maladjustment in pd patients candidate for subthalamic stimulation, and their caregivers, in a randomized controlled study.

after inclusion, patients (and their caregivers) are randomized into two groups stratified on their preoperative social adjustment scale couple domain score : usual treatment and psychoeducational programme or usual treatment alone (figure). the psychoeducational programme focuses on 3 domains: 1) neurosurgical procedure and neurological outcome, 2) social life including work, social and familial relationship, 3) couple relationship. the programme consists of 7 sessions with 3 to 4 couples at the same session, except for the 'couple relationship' domain. each domain is tackled in a two-way manner with information/education proved by the investigator and discussion of the patients' and caregivers' expectations during one session. the following session started with a 'questions and answers' on the previous domain and then information on another domain. four sessions were carried out prior to surgery and 3 after.

Eligibility criteria:
inclusion criteria: * parkison's disease * patients candidate for stn dbs * caregiver agreeing to participate * signed informed consent exclusion criteria: * contra-indication to stn-dbs * no caregiver agreeing to participate * dementia * severe ongoing psychiatric disorder
study of proton versus photon beam radiotherapy in the treatment of head and neck cancer

Conditions: Head and Neck Cancer

Summary: compared to imrt, pbrt is thought to give less radiation exposure to the surrounding healthy tissues. it is possible that side effect rates with pbrt will be lower or the same compared to imrt, but this has not been well studied to date. although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether pbrt is better, the same or worse than imrt.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18. * histopathologically confirmed diagnosis of one the following cancer types: * salivary gland cancer * skin cancer * melanoma * hnscc that require ipsilateral radiation * patients must be a candidate for ipsilateral radiation therapy. * karnofsky performance status ≥70. * negative pregnancy test for women of childbearing potential (\<51 years of age) as per institutional policy. exclusion criteria: * any prior head or neck irradiation. * physician recommendation of bilateral neck radiation. * non-resectable disease * physician recommendation of mucosal radiation

Keywords: proton-beam radiation therapy (pbrt) intensity-modulated radiation therapy (imrt) 16-1416
voice analysis technology to detect and manage depression and anxiety in cardiac rehabilitation

Conditions: Myocardial Infarction

Summary: the purpose of this study is to learn if a voice analysis smartphone app which detects anxiety and depression could be used along with cardiac rehabilitation to improve results compared to cardiac rehabilitation alone.


Eligibility criteria:
inclusion criteria: * enrolled in cardiac rehabilitation program to start within 3 months from hospital discharge. * owns a smartphone. * willing to download and use a smartphone app. * able to read, write, and speak english. exclusion criteria: * actively treated for an anxiety or depressive disorder through psychotherapy or pharmacologic treatments. * cardiac transplant. * active substance use. * neurocognitive disorder. * active psychosis. * mania diagnosis. * active suicidality

Keywords: cardiac rehabilitation
dynamic posture and head position in kyphotic female and male

Conditions: Kyphosis Thoracic; Postural, Thoracic Kyphosis; Postural Kyphosis

Summary: this study examined the comparison of dynamic posture and head position in kyphotic ındividuals according to gender. methods: a total of 54 female and male adolescents (between the ages of 12 and 18) with a thoracic kyphosis (tk) angle of ≥ 50° were divided into two groups according to gender. the kyphosis angle, dynamic postural performance, and forward head position were measured using a flexible ruler, mathiass test, and occiput wall distance.

this study examined the comparison of dynamic posture and head position in kyphotic ındividuals according to gender. methods: this observational cross-sectional study was conducted with 54 subjects. subjects aged 12 to 18 years with a kyphosis angle of ≥50º and the children and their parents who agreed to participate in the study were included. individuals with scheurmann kyphosis, scoliosis (cobb angle \>10°), and other congenital spine abnormalities were excluded. the kyphosis angle was measured using a smartphone inclinometer. dynamic posture was assessed using the matthias test. head position was obtained using occiput-wall distance.

Eligibility criteria:
inclusion criteria: * subjects with a kyphosis angle of ≥50º and the children and their parents who agreed to participate in the study were included. exclusion criteria: * individuals with scheurmann kyphosis, scoliosis (cobb angle \>10°), and other congenital spine abnormalities were excluded.
the effect of paravertebral block using a multi-orifice catheter on preventing acute and chronic post-thoracotomy pain

Conditions: Acute Postthoracotomy Pain; Chronic Postthoracotomy Pain; Hypotension After Bolus Dose

Summary: this study aims to evaluate the effect of the paravertebral block using a multi-lumen catheter on the incidence and severity of acute and chronic postthoracotomy pain compared to the thoracic epidural block.


Eligibility criteria:
inclusion criteria: * patients receiving surgery through a thoracotomy incision exclusion criteria: * patients with cardiovascular disease * patients with neurologic disease * patients with contraindications to paravertebral block or epidural block * patients with history of previous thoracotomy incision * patients with pain at the expected incision site

Keywords: postthoracotomy pain
effectiveness of bronchoscopic interventions for malignant airway obstruction

Conditions: Lung Cancer

Summary: the goal of this clinical research study is learn about side effects and the success of bronchoscopies when performed in cancer patients with and without symptoms. this is an investigational study. up to 110 patients will take part in this study. all will be enrolled at md anderson.

if participant agrees to take part in this study, researchers will collect information from participant's medical records. length of study: researchers will continue to collect participant's medical information for up to 2 years. additional information: participant's data will be kept in a database on a password-protected computer in a secure office. this information will only be available to the study doctors and staff.

Eligibility criteria:
inclusion criteria: ° all patients undergoing interventional bronchoscopy during the first 12 months will be enrolled, with follow-up occurring out to 2 years from the study startup (the duration of the grant). exclusion criteria: * age less than 18 years, * inability to participate in telephone follow-up

Keywords: lung cancer data collection post bronchoscopy
high-intensity rosuvastatin and moderate-intensity rosuvastatin/ezetimibe in ascvd patients

Conditions: ASCVD

Summary: this study will evaluate the efficacy and safety of high-intensity rosuvastatin and moderate-intensity rosuvastatin/ezetimibe in ascvd patients.


Eligibility criteria:
inclusion criteria: 1. aged 19 to 75 years 2. patients diagnosed with ascvd (coronary artery disease) * acute coronary syndrome * history of myocardial infarction (mi) * stable or unstable angina * history of coronary revascularization * stroke or transient ischemic attack (tia) * peripheral arterial disease, history of peripheral arterial revascularization 3. taking a stable dose of a statin or a lipid-lowering agent of ezetimibe over 4 weeks before randomization 4. written informed consent exclusion criteria: 1. administration of other lipid lowering agents than statin or ezetimibe within 3 months prior to screening visit 2. fasting triglyceride ≥ 400 mg/dl 3. history of muscular disease or rhabdomyolysis due to use of statin 4. hypersensitive to rosuvastatin or ezetemibe 5. contraindications stated in the spc of rosuvastatin or rosuvastatin/ezetimibe including the following: ① severe renal disease (crcl \< 30ml/min: cockcroft-gault formula or estimated gfr (mdrd) \< 30ml/min/1.73m2) ② alt, ast \> 3x uln or history of active liver disease ③ cpk \> 3x uln 6. administration of other investigational products within 30 days prior to screening visit 7. other than the above who is deemed to be ineligible to participate in the trial by investigator
clinic-based atopic dermatitis therapeutic patient education

Conditions: Atopic Dermatitis

Summary: the primary objective of this randomized trial is to determine whether comprehensive, accessible, and animation-style videos are a more effective method of therapeutic patient education (tpe) based on clinical outcomes than paper handouts in spanish and english-speaking communities. the clinical outcomes being measured are the severity, sleep affected by atopic dermatitis (ad), and the amount of itch experienced.

patients will be recruited, stratified, and then randomly assigned into one of two intervention groups.the patient participants will be children anywhere on the spectrum of mild to severe ad and they will be stratified into four strata: a) those with severe ad and no medical intervention escalation, b) those with mild ad and no medical intervention escalation, c) those with severe ad and medical intervention escalation, and d) those with mild ad and medical intervention escalation. group 1 will be a paper handout for group 1 and an educational video for group 2 as a form of tpe. subjects will be recruited in clinic after they are screened for ad during their regular dermatology appointment. the research team will provide the patient and parent with a brief introduction to the study, what it involves for the patient, any foreseeable risks, and the compensation. if they agree to participate, a consent/permission form will be given to the parent/guardian to sign. after an initial evaluation of the patient's ad, subjects will receive an initial survey and poem questionnaire on an ipad via redcap that will address the condition of their ad. the patient will be administered a form of tpe as the intervention. the intervention will first be viewed/read in clinic, followed by a brief set of questions from the research team to determine the amount of information retained on an immediate level. a follow-up appointment will be scheduled for the patient. group 2 will receive a slip of paper with a link to the videos, so the tpe will be accessible outside the clinic.

Eligibility criteria:
inclusion criteria: * boston medical center (bmc) patients under the age of 18 diagnosed with ad and their parents/legal guardian * spanish or english speakers * have access to the internet exclusion criteria: * none

Keywords: therapeutic patient education printed handouts educational videos child-parent dyads